Class II — Maquet Cardiovascular Us Sales, Llc
| Recalling firm | Maquet Cardiovascular LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species. |
| Product | Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less. |
| Quantity | 305 units |
| Distribution | Worldwide Distribution - US Nationwide |
| Initiated | 2016-09-27 |
| Classified | 2016-11-02 |
| Terminated | 2019-08-19 |
| Recall number | Z-0348-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Maquet Cardiovascular Us Sales, Llc (Z-0348-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75271/
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